Summary Of Ketorolac Tromethamine

854 Words 4 Pages
The invention relates to formulation of Ketorolac Tromethamine and Phenylephrine Hydrochloride immediate release tablet having less disintegration time. HPLC method was developed and validated for determination of content of Ketorolac Tromethamine and Phenylephrine Hydrochloride in immediate release tablet. UV spectrophotometric method was developed and validated to study drug release profile of Ketorolac Tromethamine and Phenylephrine Hydrochloride in immediate release tablet.
Background:
Ketorolac Tromethamine is a pyrrolizine carboxylic acid derivative structurally related to indomethacin. It is an anti inflammatory drug with analgesic and anti pyretic effect. Phenylephrine Hydrochloride is a sympathomimetic amine that acts predominantly
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The formulation can be used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. The injectable dosage form have problem of patient non compliance.

The present invention is related to formulation of immediate release tablet containing Ketorolac Tromethamine and Phenylephrine Hydrochloride as an active ingredients having less disintegration time which increases onset of action by decreasing drug release time. Immediate release tablet is easy to administer compare to injectable dosage form. Summary of the
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During formulation development, 3 different disintegrating agent s, were utilized to prepare immediate release tablet which are Sodium starch glycolate, Crospovidone and Cross carmellose sodium. Tablets were evaluated for disintegration time. Sodium starch glycolate, Crospovidone and Cross carmellose sodium gives disintegration time 24 sec, 44 sec and 120sec respectively. From that sodium starch glycolate gives less disintegration time and selected for the formulation of tablet

Three different concentration 2.5 mg, 5 mg and 7.5 mg of sodium starch glycolate as a disintegrating agent were used. Tablets were evaluated for the hardness and disintegration time. 5% sodium starch glycolate indicated less disintegration time and optimum hardness.

Binders are used to improve the mechanical strength of the formulation. Starch as a binder was tried with three different concentrations, 3 mg, 5 mg and 7 mg, and tablets were evaluated for the hardness and disintegration time. From optimum hardness and less disintefration time, 5% starch is optimised as a binding

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